Home - Prequalification: Active
Pharmaceutical Ingredients - List of Prequalified APIs
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Prequalification of Active Pharmaceutical Ingredients - List of Prequalified APIs
This list contains sources of
active pharmaceutical ingredients (APIs) that have been assessed
as part of the WHO Prequalification Programme and found to
be acceptable, in principle, for use in finished
pharmaceutical products procured by UN agencies. Prequalification of APIs generally involves evaluation of data relating to their quality as well as inspection of the relevant manufacturing site, as described elsewhere on this web site. The APIs listed are those for which - at the time of assessment - submitted data and information submitted were found to meet WHO norms and standards and for which - at the time of inspection - the relevant manufacturing sites were found to comply with Good Manufacturing Practices. Some of the APIs have been listed on the basis of assessment and inspection carried out by regulatory authorities who are willing to share information with WHO.
Related Link:
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WHO List of Prequalified Active Pharmaceutical
Ingredients